Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-25 @ 2:37 AM
NCT ID:
NCT07293234
Brief Summary:
Rationale: Although simethicone improves mucosal clarity, in vitro evidence suggests that its surfactant properties may disrupt bacterial adherence or viability. These findings raise concerns that simethicone may negatively affect the sensitivity of endoscopic-based H. pylori diagnostic methods. To date, no prospective in vivo study has evaluated whether simethicone influences H. pylori detection through endoscopic sampling. This randomized paired trial is designed to address this gap in evidence and evaluate whether simethicone administration reduces diagnostic yield.
Hypothesis: We hypothesize that simethicone administration prior to upper gastrointestinal endoscopy may reduce the detection rate of H. pylori by interfering with bacterial detection and diagnostic test performance.
Note on Pilot Study Design: This is a pilot study to test feasibility and inform the design of a larger future trial.
Objectives :
To evaluate whether oral administration of simethicone prior to endoscopy reduces the diagnostic yield of H. pylori using rapid urease test (RUT) To evaluate whether oral administration of simethicone impacts the detection of H. pylori by other diagnostic methods, including histology, PCR, culture and Urea Breath Test performed during endoscopy.
To explore variability in detection methods and determine feasibility for a future larger trial.
Study:
NCT07293234
Study Brief:
Protocol Section:
NCT07293234